Increase in US drug recalls and warning caused by manufacturing errors and regulatory non-compliance issues, says GBI

The numbers of warning letters and drug recalls issued by and reported to the US Food and Drug Administration (FDA) are increasing; this is causing a significant loss of revenues for pharmaceutical companies, according to a new report from GBI Research.

The number of warning letters Issued by the US FDA has increased from 117 in 2007 to 523 in 2010 at a compound annual growth rate (CAGR) of 65%

The adulteration of active ingredients and contamination of finished products are key causes of warning letters and drug recalls. The major therapy area with the highest number of drug product recalls reported was lifestyle disorders. Erectile dysfunction and sexual disorders are the two most common lifestyle disorders in which a high number of product recalls was noted. Product recalls in these indications are more frequent and it is increasing.